Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000699-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study assessed the safety and the dose of the combination of INC280 and buparlisib (BKM120), as well as the anti-tumor activity of the combination, in patients with recurrent glioblastoma with PTEN mutations, homozygous deletion of PTEN or PTEN negative by IHC. In addition, the anti-tumor activity of INC280 single agent should have been assessed in patients with recurrent glioblastoma with c-Met alteration.
This was a multi-center, open-label, phase Ib/II study. The aim of the phase Ib part was to estimate the MTD and/or to identify the recommended phase II dose (RP2D) for the combination of INC280 and buparlisib, followed by the phase II part to assess the clinical efficacy of INC280 single agent and in combination with buparlisib (BKM120), and to further assess the safety of the combination. In addition, a surgical arm should have started concurrently with the phase II part, to determine the PK/PD profile of the study drug combination in patients undergoing tumor resection for recurrent glioblastoma after 7 to 10-days treatment.
RP2D was not declared due to a lack of efficacy of the combination in the phase Ib stage, and phase II was continued with INC280 monotherapy only.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase Ib | Experimental | To estimate the safe dose of the combination INC280 and buparlisib |
|
| Phase II | Experimental | To estimate anti-tumor efficacy of INC280 single agent and in combination with buparlisib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INC280 | Drug | Phase Ib: INC280 was given at the starting dose of 200mg capsules twice daily with escalation to higher strengths. Phase II: INC280 was given at the dose of 400mg (tablets) twice daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reporting Dose Limiting Toxicities (DLTs) in Cycle 1 | A DLT is defined as an adverse event or abnormal laboratory value where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment (28 days) with INC280 in combination with buparlisib and meets any of the pre-defined criteria. The maximum tolerated dose was identified as INC280 300 mg BID + buparlisib 80 mg QD. | Cycle 1, 28 days |
| Phase II: Progression Free Survival Rate (PFSR) | Estimated rate of patients treated during 6 months without experiencing disease progression. The Progression Free Survival Rate at 6 months was to be estimated using a Bayesian model described in the protocol. The models operating characteristics were evaluated based on the enrollment of at least 30 patients enrolled. Patients did not reach the milestone for the PFSR analysis (trial terminated); as such no analysis was performed. | 6 months |
| Phase II Surgical Arm: Concentrations of INC280 and Buparlisib in Tumor. | Concentrations of INC280 and buparlisib in tumor tissue. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | To characterize the safety of INC280 single agent and in combination with buparlisib including type, frequency, severity of adverse events, serious adverse events, and dose interruptions and adjustments. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, unless otherwise specified. If CTCAE grading did not exist for an AE, the severity of mild, moderate, severe, and lifethreatening, corresponding to Grades 1 - 4, were used. CTCAE Grade 5 (death) was not used in this study but was collected as a seriousness criterion; rather, information about deaths was collected though a Death form. |
Not provided
Inclusion Criteria:
≥ 18 years of age.
Histologically confirmed diagnosis of glioblastoma (after initial tumor resection or biopsy) with radiographic evidence of recurrent tumor per RANO criteria.
Phase Ib: Documented evidence of PTEN mutations, homozygous deletion of PTEN or PTEN negative (H Score <10) by IHC confirmed by local or central assessment.
Phase II: Documented evidence of c-Met amplification (GCN>5) (fusion transcripts or mutant c-Met may be eligible after discussion with Novartis) or PTEN mutations, homozygous deletion of PTEN or PTEN negative (H Score <10) by central assessment.
Must have received the following treatment for glioblastoma:
•Prior treatment with radiotherapy and temozolomide; Note: A maximum of two prior chemotherapy/antibody regimens (including bevacizumab or other direct VEFG/VEGFR inhibitors) for recurrent disease are permitted.
Representative archival tumor sample from glioblastoma (formalin-fixed paraffine embedded tissue) must be available.
ECOG performance status ≤ 2.
Able to swallow and retain oral medication.
Patients in the surgical arm only: patients with recurrent glioblastoma must be eligible for surgical resection as deemed by the site Investigator.
Exclusion Criteria:
Prior or current treatment with a c-MET inhibitor or HGF-targeting therapy
Prior treatment with a PI3K and/or mTOR inhibitors for glioblastoma or for pre-existing neoplasm transformed to glioblastoma (applicable for combination treatment arm only)
Received radiation (including therapeutic radioisotopes such as strontium 89) therapy ≤ 3 months prior to the first dose of study treatment and have not recovered from side effects of such therapy (≤ Grade 1) prior to the first dose of study treatment, except for alopecia.
Receiving treatment with medications that are known strong inhibitors or inducers of CYP3A, and cannot be discontinued 7 days prior to the start of the treatment and during the course of the study.
Receiving treatment with medications that are known CYP3A, CYP1A2, CYP2C8, CYP2C9 or CYP2C19 substrates with narrow therapeutic index, and cannot be discontinued during the course of the study.
Receiving treatment with long acting proton pump inhibitors, and cannot be discontinued 3 days prior to the start of INC280 treatment and during the course of the study.
Currently receiving warfarin or other coumadin-derived anticoagulants for treatment, prophylaxis or otherwise.
Currently receiving increasing or chronic treatment ( > 5 days) with corticosteroids (e.g. dexamethasone > 4 mg/day or other corticosteroids equivalent dose) or another immunosuppressive agent.
History of acute or chronic pancreatitis or any risk factors that may increase the risk of pancreatitis.
Active cardiac disease or a history of cardiac dysfunction.
Impairment of gastrointestinal (GI) function or GI disease that might significantly alter the absorption of study drug
Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to DSM- IV).
Anxiety ≥ CTCAE grade 3
Any of the following baseline laboratory values:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute SC | Boston | Massachusetts | 02215 | United States | ||
| Columbia University Medical Center- New York Presbyterian Dept of Oncology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31776899 | Derived | van den Bent M, Azaro A, De Vos F, Sepulveda J, Yung WKA, Wen PY, Lassman AB, Joerger M, Tabatabai G, Rodon J, Tiedt R, Zhao S, Kirsilae T, Cheng Y, Vicente S, Balbin OA, Zhang H, Wick W. A Phase Ib/II, open-label, multicenter study of INC280 (capmatinib) alone and in combination with buparlisib (BKM120) in adult patients with recurrent glioblastoma. J Neurooncol. 2020 Jan;146(1):79-89. doi: 10.1007/s11060-019-03337-2. Epub 2019 Nov 27. |
Not provided
Not provided
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
A total of 43 patients enrolled in this trial, 33 patients in the Phase Ib part of the study (patients were assigned to 6 dose combinations of INC280 with buparlisib) and 10 patients in the Phase II part of the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 200 mg BID Cap+50 mg QD | Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib. |
| FG001 | 400 mg BID Cap+50 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Buparlisib | Drug | Buparlisib was given at the starting dose of 50mg once daily with escalation to higher strengths. |
|
|
| throughout the duration of the trial, approximately 3 years from FPFV to LPLV |
| Pharmacokinetic Profile of INC280 - AUCtau | Plasma concentration profile of INC280 in combination with Buparlisib. AUCtau is the AUC from time zero to the end of dosing interval. | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| Pharmacokinetic Profile of INC280 - Cmax | Plasma concentration profile of INC280 in combination with Buparlisib. Cmax is the Maximum (peak) observed drug concentration after dose administration. | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| Pharmacokinetic Profile of INC280 - Tmax | Plasma concentration profile of INC280 in combination with Buparlisib. Tmax is the time to reach maximum (peak) observed concentration (Cmax) after dose administration | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| Pharmacokinetic Profile of INC280 - T1/2 | Plasma concentration profile of INC280 in combination with Buparlisib. T1/2 is the terminal half life | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| Pharmacokinetic Profile of Buparlisib - AUCtau | Plasma concentration profile of Buparlisib in combination with INC280. AUCtau is the AUC from time zero to the end of dosing interval. | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| Pharmacokinetic Profile of Buparlisib - Cmax | Plasma concentration profile of INC280 in combination with Buparlisib. Cmax is the Maximum (peak) observed drug concentration after dose administration. | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| Pharmacokinetic Profile of Buparlisib - Tmax | Plasma concentration profile of INC280 in combination with Buparlisib. Tmax is the time to reach maximum (peak) observed concentration (Cmax) after dose administration | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| Pharmacokinetic Profile of Buparlisib - T1/2 | Plasma concentration profile of INC280 in combination with Buparlisib. T1/2 is the terminal half life | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| Best Overall Response (BOR) | Best Overall Response (BOR) observed in the study population of INC280 Single Agent and in Combination with Buparlisib. Responses will be assessed by the investigators following the RANO criteria with MRI or CT scans scheduled every 8 weeks. Summary of the RANO response criteria: CR has no T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; PR has ≥50% decrease T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; SD has ≥50% decrease but <25% increase T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; PD has ≥25% increase in T1-Gd+ (enhancing lesion), increase T2/FLAIR (non-enhancing lesion), presence of new lesion, deterioration in clinical status. | throughout the duration of the trial - approximately 3 years (from FPFV to LPLV) |
| Overall Survival (OS) | Survival rate of patients from start of treatment to date of death due to any cause. Patients did not reach the milestone for the survival data analysis (terminated early); as such no analysis was done. | throughout the duration of the trial - approximately 3 years (FPFV to LPLV) |
| New York |
| New York |
| 10032 |
| United States |
| Memorial Sloan Kettering Cancer Center Neurology | New York | New York | 90033 | United States |
| Duke University Medical Center Duke - Baker | Durham | North Carolina | 27710 | United States |
| University of Texas MD Anderson Cancer Center SC-3 | Houston | Texas | 77030 | United States |
| Novartis Investigative Site | Bonn | 53105 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| ErasmusMC Cancer Institute - Neurooncology, RM G3-55 | Rotterdam | 3075EA | Netherlands |
| University Medical Center Utrecht, Rm Q05.4.300, P.O. Box 85500 | Utrecht | 3508 GA | Netherlands |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Sankt Gallen | 9007 | Switzerland |
| FG002 | 500 mg BID Cap+50 mg QD | Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib. |
| FG003 | 500 mg BID Cap+80 mg QD | Phase Ib: The combination of 500 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib. |
| FG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| FG005 | 400 mg BID Tab +80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| FG006 | 400 mg BID Tab | Phase II: 400 mg INC280 (BID) tablet |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set (FAS): The FAS comprised all patients who received at least one full or partial dose of study treatment. Patients were classified according to the planned treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 200 mg BID Cap+50 mg QD | Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib. |
| BG001 | 400 mg BID Cap+50 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib. |
| BG002 | 500 mg BID Cap+50 mg QD | Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib. |
| BG003 | 500 mg BID Cap+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib. |
| BG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| BG005 | 400 mg BID Tab +80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| BG006 | 400 mg BID Tab | Phase II: 400 mg INC280 (BID) tablet |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Reporting Dose Limiting Toxicities (DLTs) in Cycle 1 | A DLT is defined as an adverse event or abnormal laboratory value where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment (28 days) with INC280 in combination with buparlisib and meets any of the pre-defined criteria. The maximum tolerated dose was identified as INC280 300 mg BID + buparlisib 80 mg QD. | Dose determining set (DDS) consisted of all patients from the SAS who either met the minimum exposure criterion and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1. | Posted | Number | Number of Patients | Cycle 1, 28 days |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Phase II: Progression Free Survival Rate (PFSR) | Estimated rate of patients treated during 6 months without experiencing disease progression. The Progression Free Survival Rate at 6 months was to be estimated using a Bayesian model described in the protocol. The models operating characteristics were evaluated based on the enrollment of at least 30 patients enrolled. Patients did not reach the milestone for the PFSR analysis (trial terminated); as such no analysis was performed. | Based on the phase I, a RP2D was not determined for the combination arm (Phase II combination arms were not opened). Patients did not reach the milestone needed for the PFSR analysis (at minimum the Bayesian model requires 30 patients) due to early termination, as such no analysis for PFSR was performed. | Posted | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Phase II Surgical Arm: Concentrations of INC280 and Buparlisib in Tumor. | Concentrations of INC280 and buparlisib in tumor tissue. | Based on the phase I, a RP2D was not determined for the combination and the phase II combination arms were not opened. | Posted | 7 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | To characterize the safety of INC280 single agent and in combination with buparlisib including type, frequency, severity of adverse events, serious adverse events, and dose interruptions and adjustments. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, unless otherwise specified. If CTCAE grading did not exist for an AE, the severity of mild, moderate, severe, and lifethreatening, corresponding to Grades 1 - 4, were used. CTCAE Grade 5 (death) was not used in this study but was collected as a seriousness criterion; rather, information about deaths was collected though a Death form. | Safety Analysis Set (SAS): The SAS comprised all patients who received at least one full or partial dose of study treatment. Patients were analyzed according to the treatment actually received. The SAS was used for all safety analyses. | Posted | Number | Participants | throughout the duration of the trial, approximately 3 years from FPFV to LPLV |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of INC280 - AUCtau | Plasma concentration profile of INC280 in combination with Buparlisib. AUCtau is the AUC from time zero to the end of dosing interval. | Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile. | Posted | Median | Full Range | hr*ng/ml | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of INC280 - Cmax | Plasma concentration profile of INC280 in combination with Buparlisib. Cmax is the Maximum (peak) observed drug concentration after dose administration. | Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile. | Posted | Median | Full Range | ng/ml | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of INC280 - Tmax | Plasma concentration profile of INC280 in combination with Buparlisib. Tmax is the time to reach maximum (peak) observed concentration (Cmax) after dose administration | Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile. | Posted | Median | Full Range | hr | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of INC280 - T1/2 | Plasma concentration profile of INC280 in combination with Buparlisib. T1/2 is the terminal half life | Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile. | Posted | Median | Full Range | hr | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of Buparlisib - AUCtau | Plasma concentration profile of Buparlisib in combination with INC280. AUCtau is the AUC from time zero to the end of dosing interval. | Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile. | Posted | Median | Full Range | hr*ng/ml | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of Buparlisib - Cmax | Plasma concentration profile of INC280 in combination with Buparlisib. Cmax is the Maximum (peak) observed drug concentration after dose administration. | Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile. | Posted | Median | Full Range | ng/ml | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of Buparlisib - Tmax | Plasma concentration profile of INC280 in combination with Buparlisib. Tmax is the time to reach maximum (peak) observed concentration (Cmax) after dose administration | Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile. | Posted | Median | Full Range | hr | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Profile of Buparlisib - T1/2 | Plasma concentration profile of INC280 in combination with Buparlisib. T1/2 is the terminal half life | Pharmacokinetic analysis set (PAS): The PAS consisted of all patients who provided an evaluable PK profile. | Posted | Median | Full Range | hr | Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1, approximately 6 months |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Best Overall Response (BOR) | Best Overall Response (BOR) observed in the study population of INC280 Single Agent and in Combination with Buparlisib. Responses will be assessed by the investigators following the RANO criteria with MRI or CT scans scheduled every 8 weeks. Summary of the RANO response criteria: CR has no T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; PR has ≥50% decrease T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; SD has ≥50% decrease but <25% increase T1-Gd+ (enhancing lesion), stable or decrease T2/FLAIR (non-enhancing lesion), absence of new lesion, stable or improve in clinical status; PD has ≥25% increase in T1-Gd+ (enhancing lesion), increase T2/FLAIR (non-enhancing lesion), presence of new lesion, deterioration in clinical status. | FAS | Posted | Number | Participants | throughout the duration of the trial - approximately 3 years (from FPFV to LPLV) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Survival rate of patients from start of treatment to date of death due to any cause. Patients did not reach the milestone for the survival data analysis (terminated early); as such no analysis was done. | Based on the phase I, a RP2D was not determined for the combination arm (Phase II combination arms were not opened). Patients did not reach the milestone needed for the OS analysis (at minimum the Bayesian model requires 30 patients) due to early termination, as such no analysis for OS was done. | Posted | throughout the duration of the trial - approximately 3 years (FPFV to LPLV) |
|
|
Treatment Emergent Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit, approximately 3 years.
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events fields "number of deaths resulting from adverse events" all those deaths, resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | INC280 200 mg BID Tab | Phase II: 200mg INC280 (BID) tablet in Phase II. A patient never received the intended PhII dose as planned (400 mg BID) but is resented as a separate group for safety. | 1 | 1 | 0 | 1 | ||
| EG001 | 200 mg BID Cap+50 mg QD | Phase Ib: The combination of 200mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib. | 3 | 5 | 5 | 5 | ||
| EG002 | 400 mg BID Cap + 50 mg QD | Phase Ib: The combination of 400mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib. | 2 | 6 | 6 | 6 | ||
| EG003 | 500 mg BID Cap+50 mg QD | Phase Ib: The combination of 500mg INC280 (BID) capsule and 50 mg Buparlisib (QD) once daily for Phase Ib. | 3 | 4 | 4 | 4 | ||
| EG004 | 500 mg BID Cap+80 mg QD | Phase Ib: The combination of 500mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib. | 3 | 6 | 6 | 6 | ||
| EG005 | 300 mg BID Tab+ 80 mg QD | Phase Ib: The combination of 300mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib. | 3 | 7 | 7 | 7 | ||
| EG006 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400mg INC280 (BID) capsule and 80 mg Buparlisib (QD) once daily for Phase Ib. | 4 | 5 | 5 | 5 | ||
| EG007 | All Patients (Phase Ib) | Phase Ib: All Patients with the combination of INC280 (BID) and Buparlisib (QD) once daily. | 18 | 33 | 33 | 33 | ||
| EG008 | 400 mg BID Tab | Phase II: 400mg INC280 (BID) tablet in Phase II. | 2 | 9 | 9 | 9 | ||
| EG009 | All Patients (Phase II) | Phase II: All patients treated with INC280 (BID) tablet once daily in the Phase II. | 3 | 10 | 9 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GASTRIC ULCER | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FEBRILE INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PERITONITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NEUROLOGICAL DECOMPENSATION | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARAPARESIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARTIAL SEIZURES | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| APATHY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SINUS BRADYCARDIA | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIPLOPIA | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VISION BLURRED | Eye disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSPHAGIA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RECTAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GAIT DISTURBANCE | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERBILIRUBINAEMIA | Hepatobiliary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| ORCHITIS | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| |
| CONTUSION | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| LACERATION | Injury, poisoning and procedural complications | MedDRA (19.1) | Systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| AMYLASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD ALBUMIN DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD GLUCOSE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD POTASSIUM INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| BLOOD TRIGLYCERIDES INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| GLOMERULAR FILTRATION RATE DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| INSULIN C-PEPTIDE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| LIPASE INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| LYMPHOCYTE COUNT DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| NEUTROPHIL COUNT DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| PLATELET COUNT DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| PROTEIN TOTAL DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| PROTHROMBIN TIME PROLONGED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA (19.1) | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| AMNESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| APHASIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ATAXIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BRAIN OEDEMA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| COGNITIVE DISORDER | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DISTURBANCE IN ATTENTION | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSARTHRIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSKINESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DYSMETRIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FACIAL PARALYSIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| FACIAL PARESIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HEMIANOPIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HEMIANOPIA HOMONYMOUS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HEMIPARESIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HEMIPLEGIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| LETHARGY | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MEMORY IMPAIRMENT | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NEUROLOGIC NEGLECT SYNDROME | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| NEUROLOGICAL SYMPTOM | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARALYSIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARAPARESIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PARESIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PERIPHERAL MOTOR NEUROPATHY | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PYRAMIDAL TRACT SYNDROME | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RESTLESS LEGS SYNDROME | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TREMOR | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| VITH NERVE PARALYSIS | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
| |
| AGITATION | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ANXIETY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| APATHY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BRADYPHRENIA | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DEPRESSED MOOD | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DISORIENTATION | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| IRRITABILITY | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MOOD ALTERED | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PERSONALITY CHANGE | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SLEEP DISORDER | Psychiatric disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CHRONIC KIDNEY DISEASE | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| CYSTITIS NONINFECTIVE | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMATURIA | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| MICTURITION URGENCY | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
| |
| TESTICULAR PAIN | Reproductive system and breast disorders | MedDRA (19.1) | Systematic Assessment |
| |
| BRONCHOSPASM | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DERMATITIS ACNEIFORM | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH MACULAR | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| RASH MACULO-PAPULAR | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| SKIN ATROPHY | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
| |
| EMBOLISM | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HAEMATOMA | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
| |
| HYPOTENSION | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
At the end of Phase Ib, it was decided not to enroll patients in the two Phase II arms evaluating INC280 with buparlisib. The phase II INC280 single agent arm was halted before it reached target enrollment.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D001932 | Brain Neoplasms |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613976 | capmatinib |
| C571178 | NVP-BKM120 |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Nausea |
|
| Aspartate Aminotransferase Increased |
|
| 500 mg BID Cap+50 mg QD |
Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib. |
| OG003 | 500 mg BID Cap+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG004 | 300 mg BID Tab + 80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab + 80 mg QD | Phase Ib: the combination of 400 mg INC280 (BID) tablet and 80 mg Buparlisib (QD) once daily |
| OG006 | 400 mg BID Tab | Phase II: 400 mg INC280 (BID) tablet |
|
|
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
|
|
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
|
|
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
|
|
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
|
|
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
|
|
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
|
|
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
|
|
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
|
|
| OG002 |
| 500 mg BID Cap+50 mg QD |
Phase Ib: The combination of 500 mg INC280 (BID) capsule and 50mg Buparlisib (QD) once daily for Phase Ib. |
| OG003 | 500 mg BID Cap+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG004 | 300 mg BID Tab +80 mg QD | Phase Ib: The combination of 300 mg INC280 (BID) tablet and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG005 | 400 mg BID Tab+80 mg QD | Phase Ib: The combination of 400 mg INC280 (BID) capsule and 80mg Buparlisib (QD) once daily for Phase Ib. |
| OG006 | 400 mg BID Tab | Phase II: 400 mg INC280 (BID) tablet |
|
|